2026 data FDA MAUDE openFDA

Aortic Valve, Prosthesis, Percutaneously Delivered

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Aortic Valve MID-BOOK · MAUDE

#51 of 1000 · 72,550 reports · 2004–2026

  • BOOK 72,550 reports
  • RANK #51 of 1000
  • DEATH 7,440 death-typed
  • INJ 54,455 injury-typed
  • MALF 10,640 malfunction
  • SPAN 2004–2026
  • PEAK 2025: 13,120
  • PHOTO Implant, Cochlear

Nearest event-volume peer: Implant, Cochlear (243 report gap)

Aortic Valve, Prosthesis, Percutaneously Delivered sits #51 of 1000 among tracked device types with 72,550 MAUDE reports spanning 2004–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 10.3% corpus 1.5% · above corpus mean (+8.7 pp)
  • INJ 75.1% corpus 30.4% · above corpus mean (+44.6 pp)
  • MALF 14.7% corpus 64.5% · below corpus mean (-49.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 30% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 43% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Aortic Valve in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Aortic Valve, Prosthesis, Percutaneously Delivered carries 72,550 MAUDE reports, ranked #51 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 54,455 (75.1%)
Malfunction 10,640 (14.7%)
Death 7,440 (10.3%)
12 (0.0%)
Other 3 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 45,485 (53.2%)
10,008 (11.7%)
Death 6,569 (7.7%)
R 5,999 (7.0%)
Life Threatening 3,547 (4.2%)
Hospitalization 3,062 (3.6%)
Other 2,868 (3.4%)
H 2,714 (3.2%)
L 2,491 (2.9%)
D 1,044 (1.2%)
Disability 810 (0.9%)
S 569 (0.7%)
O 276 (0.3%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 23,660
Perivalvular Leak 8,181
Patient Device Interaction Problem 7,841
Insufficient Information 6,989
Device Dislodged or Dislocated 5,791
Malposition of Device 2,597
Gradient Increase 2,173
Degraded 2,076
Material Invagination 2,060
Fluid/Blood Leak 2,014
Burst Container or Vessel 1,858
Calcified 1,854
Intravalvular regurgitation 1,836
Activation Failure 1,779
Device Stenosis 1,754
Difficult to Remove 1,624
Migration or Expulsion of Device 1,517
Difficult or Delayed Positioning 1,366
Material Deformation 1,151
Material Split, Cut or Torn 935

Yearly Trend

04
2004: 1
12
2012: 98
13
2013: 1,096
14
2014: 2,161
15
2015: 2,862
16
2016: 2,996
17
2017: 3,115
18
2018: 3,916
19
2019: 4,361
20
2020: 5,806
21
2021: 5,604
22
2022: 5,994
23
2023: 8,319
24
2024: 11,043
25
2025: 13,120
26
2026: 2,058

Related Entities for Aortic Valve, Prosthesis, Percutaneously Delivered

Event Locations

45,865 (63.2%)
I 26,526 (36.6%)
HOSPITAL 82 (0.1%)
NO INFORMATION 75 (0.1%)
OTHER 2 (0.0%)

Compare EDWARDS LIFESCIENCES vs MEDTRONIC HEART VALVES DIVISION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Aortic Valve, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (72,550 here).

Similar death-typed counts

Nearest other device types by death-typed report count (7,440 here), distinct from the volume row.

Disclaimer: MAUDE figures for Aortic Valve are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Aortic Valve; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.